Device manufacturer, as written on reports
Draeger Medical Systems: medical device reports filed with FDA
1,113 reports name it as the manufacturer of the device involved, 2004–2026.
- 1,113
- reports naming it as manufacturer
- 0% of all MAUDE reports
- 54
- reports, 12 months to August 2026
- 109 in the 12 months before
- 74.8%
- classified as malfunction
- 62.3% across all reports
- 12.7%
- classified as death, as reported
- 0.9% across all reports
1,113 medical device reports received by FDA give Draeger Medical Systems as the manufacturer of the device involved, 0% of the MAUDE database, from January 2004 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.
54 reports arrived in the 12 months to August 2026, down 50% from 109 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (74.8%), death (12.7%) and injury (9.7%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Brands named most often
| Brand | Device type | Reports | Latest 12 months | Classified as death |
|---|---|---|---|---|
| Infinity Acute Care System (M540) | Monitor, physiological, patient(with arrhythmia detection or alarms) | 233 | 19 | 9% |
| Delta | Monitor, physiological, patient(with arrhythmia detection or alarms) | 66 | 22 | 7.2% |
| Evita Xl | Ventilator, continuous, facility use | 9 | 13 | 3.8% |
| Apollo | Agent, injectable, embolic | 6 | 141 | 1.8% |
| Perseus A500 | Gas-machine, anesthesia | 5 | 42 | 2.1% |
| Infinity | Implant, endosseous, root-form | 4 | 24 | 2.1% |
| Fabius GS | Gas-machine, anesthesia | 2 | 7 | 1.6% |
| Fabius GS Premium | Gas-machine, anesthesia | 2 | 19 | 1.1% |
| Evita V800 | Ventilator, continuous, facility use | 1 | 48 | 0% |
| Symphony | Pulse generator, permanent, implantable | 1 | 133 | 1.6% |
Brands with a page on this site, ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Device types
| Product code | Device type | Reports | Share |
|---|---|---|---|
| MHX | Monitor, physiological, patient(with arrhythmia detection or alarms) | 617 | 55.4% |
| CBK | Ventilator, continuous, facility use | 246 | 22.1% |
| DSI | Detector and alarm, arrhythmia | 61 | 5.5% |
| BSZ | Gas-machine, anesthesia | 48 | 4.3% |
| FMT | Warmer, infant radiant | 34 | 3.1% |
| FMZ | Incubator, neonatal | 26 | 2.3% |
| DRT | Monitor, cardiac (incl. cardiotachometer & rate alarm) | 22 | 2% |
| DRG | Transmitters and receivers, physiological signal, radiofrequency | 14 | 1.3% |
| LBI | Unit, neonatal phototherapy | 8 | 0.7% |
| CAD | Vaporizer, anesthesia, non-heated | 3 | 0.3% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type
Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.
Questions about Draeger Medical Systems reports
How many FDA device reports name Draeger Medical Systems as manufacturer?
1,113 reports through August 2026, 54 of them in the latest 12 months.
Which of its brands appear most often?
Infinity Acute Care System (M540) (233), Delta (66), Evita Xl (9), Apollo (6) and Perseus A500 (5).
Which device types does it report on?
monitor, physiological, patient(with arrhythmia detection or alarms) (55.4%), ventilator, continuous, facility use (22.1%), detector and alarm, arrhythmia (5.5%) and gas-machine, anesthesia (4.3%).
Does a high count say something about the manufacturer?
Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.